Unique ID issued by UMIN | UMIN000008437 |
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Receipt number | R000009925 |
Scientific Title | The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema. |
Date of disclosure of the study information | 2012/07/14 |
Last modified on | 2018/07/19 09:40:47 |
The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema.
The effect of kallidinogenase for postoperative diabetic macula edema.
The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema.
The effect of kallidinogenase for postoperative diabetic macula edema.
Japan |
Diabetic macula edema
Ophthalmology |
Others
NO
To investigate the effect of kallidinogenase for postoperative in diabetic macula edema
Safety,Efficacy
Foveal retinal thickness
Visual acuity,fundus findings,recurrence of the edema,number of the exaples of aan ophthalmic treatment addition,number of the times of an addition,and period to an addition,the safety assessment(rate of adverse events)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Kallidinogenase(+)oral
Kallidinogenase(-)
20 | years-old | <= |
Not applicable |
Male and Female
Patients underwent vitrectomy for diabetic macula edema,who met the all inclusion criteria.
(a)Older than 20tears of age at the time of the acquisition agreement.
(b)Allowed to go to the Hiroshima University Hospital regularly for one year.
(c)Obtained consentin written foem of the study participants.
(a)Sever side effects by the past kallidinogenase preparations.
(b)Treated by kallidinogenase within one month of preparation before the start of this drug.
(c)HbA1c 10%.
(d)Treated with steroids or anti-VEGF drugs(drugs contraindicated in combination)
(e)Pregnant and lactating woman or woman who may become pregnant.
(f)Any others judged by the doctor in charge to be ineligible for subjects in the study.
40
1st name | |
Middle name | |
Last name | Yoshiaki Kiuchi |
Hiroshima University School of Medicine
Department of Ophthalmology
Kasumi1-2-3,Minami-ku,Hiroshima
082-257-1576
z.ohhara@tsukazaki-eye.net
1st name | |
Middle name | |
Last name | Zaigen Ohara |
Saneikai Tsukazaki Hospital
Ophthalmology
68-1,Aboshiku waku,Himeji city,Hyougo Prefecture
079-272-8555
z.ohhara@tsukazaki-eye.net
Department of Ophthalmology,Hirosima University School of Medicine
Department of Ophthalmology,Hirosima University School of Medicine
Other
Saneikai Tsukazaki Hospital Ophthalmology
NO
2012 | Year | 07 | Month | 14 | Day |
Published
Completed
2012 | Year | 07 | Month | 06 | Day |
2012 | Year | 07 | Month | 14 | Day |
2012 | Year | 07 | Month | 14 | Day |
2018 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009925
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